Atrial septal defect suturing device

Abstract

The embodiment of the invention relates to the field of surgical devices, in particular to an atrial septal defect suturing device which comprises a suturing piece, a sheathing canal, a puncture needle, a suturing line and a guide wire, the guide wire is arranged to be capable of driving the suturing piece and the puncture needle to move in the sheathing canal so as to send the suturing piece to a preset position of an atrium along the sheathing canal, and at the preset position, the puncture needle is inserted into the suturing line. The suturing piece can be unfolded and wraps the atrial septum defect, the sheath tube is arranged to be provided with an opening in one end close to a preset position, the opening is arranged to allow the puncture needle to pass through, the puncture needle is arranged to be capable of penetrating through the atrial septum, and the suturing piece is fixed to the atrial septum defect through the suturing line so that the atrial septum defect can be sutured. The suture piece is conveyed to the atrial septal defect of the heart through the guide wire and the sheathing canal, and the puncture needle can extend out of the opening in the sheathing canal so as to sequentially penetrate through the atrial septum and the suture piece, so that the atrial septum is fixedly connected with the suture piece, and the suture piece can fixedly wrap the atrial septal defect and is prevented from falling off.

Description

Technical Field

[0001] Embodiments of the present application relate to the field of surgical devices, and particularly to an atrial septal defect suture device. Background Art

[0002] The statements herein merely provide background information related to the present application and do not necessarily constitute prior art.

[0003] The atrial septum is located between the left atrium and the right atrium and is mainly used to separate the blood in the left and right atria. Under normal circumstances, the left atrium receives oxygen-rich blood from the lungs, and the right atrium receives oxygen-poor blood from the body. Atrial septal defect is a common heart disease, which is manifested as a communicating hole between the left and right atria. Atrial septal defect will cause the blood in the left and right atria to mix with each other at the through-hole, and the oxygen-rich and oxygen-poor blood will no longer enter their respective circulatory systems separately, but will be mixed with each other, resulting in a decrease in the oxygen content of the blood in the left atrium, causing symptoms such as hypoxia in the patient, and affecting the health and quality of life of the patient. Summary of the Invention

[0004] A brief overview of the present application is given below to provide a basic understanding of certain aspects of the present application. It should be understood that this overview is not an exhaustive overview of the present application. It is not intended to identify the key or important parts of the present application, nor is it intended to limit the scope of the present application. Its purpose is only to present certain concepts in a simplified form as a prelude to the more detailed description to follow.

[0005] Embodiments of the present application provide an atrial septal defect suture device, which is applicable to suture the atrial septal defect of the heart. It includes: a suture member, a sheath, a puncture needle, a suture thread, and a guide wire. The guide wire is configured to drive the suture member and the puncture needle to move within the sheath, so as to send the suture member along the sheath to a predetermined position in the atrium. At the predetermined position, the suture member is configured to be able to unfold and form a covering on the atrial septal defect. One end of the sheath near the predetermined position is formed with an opening, and the opening is configured to allow the puncture needle to pass through. The puncture needle is configured to be able to penetrate the atrial septum and use the suture thread to fix the suture member to the defect of the atrial septum, so that the atrial septal defect is sutured.

[0006] Further, the puncture needle is configured to drive the suture thread to sequentially penetrate the atrial septum and the suture member, connect the suture member with the suture thread, and drive the suture thread to penetrate the atrial septum again, so that the suture thread fixes the suture member to the defect of the atrial septum, so that the atrial septal defect is sutured.

[0007] Further, the puncture needle is formed with a thread-passing hole at a predetermined distance near its tip, and the suture thread is configured to penetrate through the thread-passing hole.

[0008] Further, a protrusion is formed on the puncture needle at a predetermined distance from the threading hole in a direction away from the tip, and the protrusion is arranged to extend in a direction away from the tip of the puncture needle to form a barb structure.

[0009] Further, the guide wire is arranged to drive the puncture needle to move in a direction away from the tip, so that the barb structure can drive the suture to move towards the atrial septum, so as to fixedly connect the suture to the atrial septum.

[0010] Further, the sheath is arranged to pass through the atrial septal defect, and the suture is arranged to be in a contracted state when moving in the sheath, and can expand and wrap around the atrial septal defect after extending out of the sheath.

[0011] Further, the sheath is arranged to move away from the atrial septum and out of the human body when the suture is fixedly connected to the atrial septum.

[0012] Further, the suture thread is arranged to be able to tie a knot and break away from the threading hole when the suture is close to the atrial septum.

[0013] Further, the puncture needle is arranged to be able to move out of the human body together with the sheath.

[0014] Further, a plurality of openings are provided, and the plurality of openings are evenly distributed in the circumferential direction of the sheath.

[0015] The atrial septal defect suture device provided by the embodiment of the present application transports the suture to the atrial septal defect of the heart through the guide wire and the sheath, so that the suture forms a wrap at the atrial septal defect, and the puncture needle can extend out of the opening on the sheath, and then sequentially pass through the atrial septum and the suture, so that the atrial septum and the suture are fixedly connected by the suture thread, so that the suture can be fixedly wrapped around the atrial septal defect to prevent the suture from falling off.

[0016] The additional aspects and advantages of the present application will become apparent in the following description section, or will be understood through the practice of the present application. What is provided in the content of the present application is only one embodiment, not the present application itself. The effects of the content of the present application are only the effects of the embodiment, not all the technical effects of the present application. BRIEF DESCRIPTION OF THE DRAWINGS

[0017] In order to further illustrate the above and other advantages and features of the present application, the following detailed description of the specific embodiments of the present application will be made in conjunction with the accompanying drawings. The accompanying drawings, together with the following detailed description, are included in this specification and form a part of this specification. Elements having the same function and structure are denoted by the same reference numerals. It should be understood that these drawings only depict typical examples of the present application and should not be regarded as limiting the scope of the present application.

[0018] Figure 1It is a side schematic view of the atrial septal defect suture device provided by the embodiments of the present application;

[0019] Figure 2 It is a schematic structural view of the cooperation between the puncture needle and the suture provided by the embodiments of the present application;

[0020] Figure 3 It is a schematic view of the atrial septal defect suture device provided by the embodiments of the present application placed at the atrial septal defect of a patient.

[0021] Explanation of reference numerals:

[0022] 10. Sheath tube; 101. Opening; 20. Puncture needle; 201. Tip; 202. Thread-passing hole; 203. Protrusion; 30. Suture piece; 40. Suture; 50. Atrial septum. Detailed implementation manners

[0023] Hereinafter, exemplary embodiments of the present application will be described in conjunction with the accompanying drawings. For clarity and conciseness, not all features of the actual implementation manners are described in the specification. However, it should be understood that many implementation-specific decisions must be made during the development of any such actual implementation manner in order to achieve the specific goals of the developer, for example, to comply with those restrictions related to the system and business, and these restrictions may vary with different implementation manners. In addition, it should also be understood that although the development work may be very complex and time-consuming, for those skilled in the art who benefit from the content of the present application, such development work is merely a routine task.

[0024] Here, it should also be noted that, in order to avoid obscuring the present application due to unnecessary details, only the device structures and / or processing steps closely related to the solution of the present application are shown in the drawings, while other details less related to the present application are omitted.

[0025] The following disclosure provides multiple different implementation manners or examples for implementing the present application. To simplify the disclosure of the present application, the components and methods of specific examples are described below. Of course, they are merely examples and are not intended to limit the present application. In the description of the embodiments of the present application, the meaning of "multiple" is at least two, such as two, three, etc., unless otherwise clearly and specifically defined.

[0026] For atrial septal defects that cannot close naturally or present symptoms, it is necessary to fill the gap between the left and right atria through surgical or minimally invasive interventional treatment methods to improve cardiac hemodynamics, reduce the shunt of oxygen-rich blood, relieve pulmonary hypertension, thereby alleviating the patient's symptoms and improving the quality of life. The inventor found that the suturing effect of existing suturing devices cannot meet the expectations: for example, due to the contact between the suture and the damaged part of the atrial septum, the suture may fall off the atrial septum during the suturing process, resulting in suturing failure.

[0027] Embodiments of the present application provide an atrial septal defect suturing device, which is applicable to suturing the atrial septal defect of the heart. Figure 1 The side schematic diagram of the atrial septal defect suturing device provided by the embodiments of the present application is shown. Figure 3 The schematic diagram of the atrial septal defect suturing device provided by the embodiments of the present application placed at the atrial septal defect of the patient is shown. In some embodiments, as Figure 1 and Figure 3 shown, the atrial septal defect suturing device includes: a suture member 30, a sheath 10, a puncture needle 20, a suture 40, and a guide wire. The guide wire is configured to drive the suture member 30 and the puncture needle 20 to move within the sheath 10 to deliver the suture member 30 along the sheath 10 to a predetermined position in the atrium. At the predetermined position, the suture member 30 is configured to be deployable and form a covering around the atrial septal defect. One end of the sheath 10 near the predetermined position is formed with an opening 101, and the opening 101 is configured to allow the puncture needle 20 to pass through. The puncture needle 20 is configured to be able to penetrate the atrial septum 50 and enable the suture 40 to fix the suture member 30 to the defective part of the atrial septum 50, so that the atrial septal defect is sutured.

[0028] The atrial septal defect suturing device provided by the embodiments of the present application transports the suture member 30 to the atrial septal defect of the heart through the guide wire and the sheath 10, so that the suture member 30 forms a covering around the atrial septal defect, and the puncture needle 20 can extend out from the opening 101 on the sheath 10, thereby sequentially penetrating the atrial septum 50 and the suture member 30, so that the atrial septum 50 and the suture member 30 are fixedly connected by the suture, so that the suture member 30 can be fixedly covered around the atrial septal defect to prevent the suture member 30 from falling off. Compared with the related art that directly sutures the atrial septum with a suture, the contact area between the suture member of the present application and the atrial septum is much larger than the contact area between the suture and the atrial septum. Therefore, the problem of the suture falling off from the suture of the atrial septum that occurs in the related art is avoided, and the success rate of suturing the atrial septal defect is greatly improved by using the atrial septal defect suturing device provided by the present application.

[0029] In some embodiments, as Figure 3As shown, the puncture needle 20 is configured to drive a suture to pass through the atrial septum 50 and the suture member 30 in sequence, connect the suture to the suture member 30, and drive the suture to pass through the atrial septum again, so that the suture fixes the suture member 30 at the defect of the atrial septum, and the defect of the atrial septum is sutured.

[0030] In some embodiments, the suture member 30 is configured to be detachably connected to a guide wire (not shown in the figure). The suture member 30 and the guide wire are disposed within the sheath 10. The suture member 30 is configured such that its size in the contracted state matches the inner diameter of the sheath 10, so that the suture member 30 can be smoothly disposed within the sheath 10. Transporting the suture member 30 to a predetermined position in the heart by means of the sheath 10 is conducive to accurately transporting the suture member 30 to the predetermined position.

[0031] In some embodiments, as Figure 3 shown, the sheath 10 is configured to pass through the atrial septal defect. The suture member 30 is configured to be in a contracted state when moving within the sheath 10, and can expand and wrap around the atrial septal defect after the suture member 30 extends out of the sheath 10.

[0032] In some embodiments, the delivery sheath 10 requires venipuncture of the patient to form a venous access for the sheath 10 to move. The sheath 10 finally moves to the atrial septal defect and passes through the hole formed by the defect, so that the suture member 30 disposed in the sheath 10 in a contracted state can wrap around one side in the direction opposite to the movement direction of the sheath 10 exiting the human body after extending out of the sheath 10. When the guide wire is separated from the suture member 30, the atrial septum 50 can play a certain stopping role when the sheath 10 leaves the atrial septal defect, avoiding dragging the suture member 30 away from the atrial septal defect.

[0033] Figure 2 The structural schematic diagram of the cooperation between the puncture needle and the suture provided by the embodiments of the present application is shown. In some embodiments, as Figure 2 shown, the puncture needle 20 is configured to have a thread-passing hole 202 formed at a predetermined distance near its tip 201, and the suture 40 is configured to pass through the thread-passing hole 202.

[0034] In some embodiments, as Figure 2 and Figure 3As shown, one end of the puncture needle 20 is provided with a tip 201 that facilitates puncture, enabling the puncture needle 20 to penetrate the atrial septum 50 and the suture 30, avoiding physical harm to the patient caused by repeated operations due to the inability to quickly penetrate and fix the suture 30. At a predetermined position away from the tip 201, a threading hole 202 is formed radially through the puncture needle 20. The threading hole 202 is used to allow the suture 40 to pass through it, so that the suture 40 can move with the puncture needle 20. Then, when the puncture needle 20 successively penetrates the atrial septum 50 and the suture 30, the suture 40 also successively penetrates the atrial septum 50 and the suture 30 accordingly, thereby connecting the atrial septum 50 and the suture 30 together through the suture 40, achieving the fixation of the suture 30 in the atrium and preventing the suture 30 from separating from the atrial septum 50 due to the force of the heart beating or blood flow during operation.

[0035] In some embodiments, as Figure 2 shown, a protrusion 203 is formed at a predetermined distance from the threading hole 202 in the direction away from the tip 201 of the puncture needle 20. The protrusion 203 is arranged to extend in the direction away from the tip 201 of the puncture needle 20 to form a barb structure.

[0036] In some embodiments, a protrusion 203 is formed at a predetermined position at the end of the threading hole 202 away from the tip 201. The protrusion 203 is arranged as a barb structure extending in the direction away from the tip 201. A streamlined shape is set between the tip 201 and the protrusion 203, and the threading hole 202 is formed between the tip 201 and the protrusion 203, enabling the suture 40 passing through the threading hole 202 to smoothly shuttle through the atrial septum 50 and the suture 30 along with the streamlined structure close to the tip 201; meanwhile, the protrusion 203 causes a predetermined part of the suture 40 to bend, avoiding the two ends of the suture 40 from being too close to the non-protruding part of the puncture needle 20, thereby preventing them from entangling or even knotting with each other.

[0037] In some embodiments, the guide wire is arranged to drive the puncture needle 20 to move in the direction away from the suture 30, so that the barb structure can drive the suture 30 to move towards the atrial septum 50 to enable the suture 30 to be fixedly connected to the atrial septum 50.

[0038] In some embodiments, when the sheath 10 moves to the atrial septal defect, the suture 30 extends and unfolds from the sheath 10, and the atrial septal defect is covered. At the same time, the puncture needle 20 in the sheath 10 extends from the opening 101 on the sheath 10, driving the suture 40 arranged in the threading hole 202 to extend out of the sheath 10 together, and successively penetrating the atrial septum 50 and the suture 30 at a predetermined angle.

[0039] In some embodiments, the sheath 10 is arranged to be able to move away from the atrial septum 50 and out of the human body when the suture 30 is fixedly connected to the atrial septum 50.

[0040] In some embodiments, the outer surface layer of the suture member 30 may be provided with a dense coating structure that does not allow blood to pass through, so as to prevent blood mixing between the left and right atria. After the puncture needle 20 penetrates the suture member 30, the barb structure formed by its protrusion 203 can drive the suture member 30 to move towards the atrial septum 50 when the sheath 10 is withdrawn from the human body, making the suture 40 fix the suture member 30 and the atrial septum more tightly, preventing there from being a space allowing the suture member 30 to move between the two, and making the suture more rigorous.

[0041] In some embodiments, the suture 40 is arranged to be able to tie a knot and detach from the threading hole 202 when the suture member 30 is close to the atrial septum 50.

[0042] In some embodiments, as Figure 2 shown, the suture 40 is arranged to penetrate through the threading hole 202, and both ends are set to a predetermined length, the predetermined length is greater than the length of the puncture needle, and both ends of the suture 40 extend freely, and sufficient lengths are reserved at both ends to avoid sufficient movement space for the suture 40 when it is subjected to external force during the puncture process, preventing the suture 40 from falling off from the threading hole 202.

[0043] In some embodiments, the puncture needle 20 is arranged to be able to move to the outside of the human body together with the sheath 10.

[0044] In some embodiments, the suture 40 ties a knot to fix the atrial septum 50 and the suture member 30 to ensure the firmness of the suture. Subsequently, the puncture needle 20 is arranged to retract into the sheath 10 from the opening 101 and be withdrawn from the human body together with the sheath 10. The sheath 10 can prevent the puncture needle 20 from scratching the blood vessel wall.

[0045] In some embodiments, as Figure 1 shown, a plurality of openings 101 are provided, and the plurality of openings 101 are evenly distributed in the circumferential direction of the sheath 10.

[0046] In some embodiments, a plurality of openings 101 can be evenly arranged on the sheath 10 to allow a plurality of puncture needles 20 to protrude therefrom, thereby driving the suture 40 to fix the atrial septum 50 and the suture member 30 together, so as to achieve multiple fixations of the suture member 30 and further improve the firmness of the suture member 30.

[0047] The following describes the usage method of the atrial septal defect suture device provided by the present application.

[0048] Use a predetermined means to determine information such as the precise location, size, and morphological characteristics of the patient's atrial septal defect, and select a suture 30 with a suitable size according to the determined information; select the location where the blood vessel connected to the heart is located as the puncture site, and generally choose femoral vein puncture; after performing preparatory work such as disinfection and local anesthesia on the patient's puncture site, puncture the patient's puncture site to form a puncture opening on the patient's epidermis; maintain the puncture opening in an expanded state, and introduce a guide wire into the venous blood vessel at the puncture site through the puncture opening.

[0049] Under the guidance of the guide wire, place the sheath 10, the suture 30 retracted in the sheath 10, and the puncture needle 20 provided with a suture 40 into the venous blood vessel at the puncture site; ensure that the sheath 10 and the suture 30 reach the atrial septal defect along a predetermined blood vessel path under the monitoring of means such as fluoroscopy and echocardiogram; after reaching the appropriate position, the suture 30 is released and expanded from the sheath 10, wherein the suture 30 can be set to expand and contract with the contraction and relaxation of the heart.

[0050] When the suture 30 expands to completely cover the atrial septal defect, the puncture needle 20 carried in the sheath 10 extends out from the opening 101 formed on the sheath 10. A thread-passing hole 202 for passing the suture 40 is formed on the puncture needle 20. The puncture needle 20 drives the suture 40 to penetrate the atrial septum 50 and the suture 30 in sequence, so that the suture 40 also passes through the atrial septum 50 and the suture 30 in sequence accordingly, thereby connecting the atrial septum 50 and the suture 30 together by the suture 40. And a barb structure is formed near the thread-passing hole 202 of the puncture needle, so that when the suture 30 leaves the atrial septal defect, it is driven by the barb structure to fit with the atrial septum 50, further strengthening the coverage of the atrial septal defect by the suture 30.

[0051] After the suture is completed, the puncture needle 20 retracts into the sheath 10 from the opening 101. The suture 40 detaches from the puncture needle from the thread-passing hole 202 and is knotted and fixed. The sheath 10, the puncture needle 20, and the guide wire are withdrawn from the human body together, and the puncture opening of the patient is pressure bandaged.

[0052] For the embodiments of the present application, it should also be noted that, without conflict, the embodiments of the present application and the features in the embodiments can be combined with each other to obtain new embodiments.

[0053] The above is only the specific implementation manner of the present application, but the protection scope of the present application is not limited thereto. The protection scope of the present application shall be subject to the protection scope of the claims.

Claims

1. An atrial septal defect suture device, which is applicable to suture the atrial septal defect of the heart, and is characterized in that It includes: a suture, a sheath tube, a puncture needle, a suture thread and a guide wire. The guide wire is configured to drive the suture and the puncture needle to move within the sheath tube, so as to send the suture along the sheath tube to a predetermined position in the atrium. At the predetermined position, the suture is configured to be able to unfold and form a covering on the atrial septal defect. One end of the sheath tube near the predetermined position is formed with an opening, and the opening is configured to allow the puncture needle to pass through. The puncture needle is configured to be able to penetrate the atrial septum and use the suture thread to fix the suture to the defect of the atrial septum, so that the atrial septal defect is sutured.

2. The device according to claim 1, wherein the puncture needle is configured to drive the suture thread to sequentially penetrate the atrial septum and the suture, connect the suture thread to the suture, and drive the suture thread to penetrate the atrial septum again, so that the suture thread fixes the suture to the defect of the atrial septum, so that the atrial septal defect is sutured.

3. The device according to claim 2, wherein the puncture needle is formed with a thread-passing hole at a predetermined distance near its tip, and the suture thread is configured to pass through the thread-passing hole.

4. The device according to claim 3, wherein a protrusion is formed on the puncture needle at a predetermined distance from the thread-passing hole in the direction away from the tip, and the protrusion is configured to extend in the direction away from the tip of the puncture needle to form a barbed structure.

5. The device according to claim 4, wherein the guide wire is configured to drive the puncture needle to move in the direction away from the tip, so that the barbed structure can drive the suture to move in the direction close to the atrial septum, so as to fixedly connect the suture to the atrial septum.

6. The device according to claim 1, wherein the sheath tube is configured to pass through the atrial septal defect, and the suture is configured to be in a contracted state when moving within the sheath tube and can unfold and wrap around the periphery of the atrial septal defect after the suture extends out of the sheath tube.

7. The device according to claim 5 or 6, wherein the sheath tube is configured to move away from the atrial septum and out of the human body when the suture is fixedly connected to the atrial septum.

8. The device according to claim 5, wherein the suture thread is configured to be able to tie a knot and disengage from the thread-passing hole when the suture is close to the atrial septum.

9. The device according to claim 7, wherein the puncture needle is configured to be able to move out of the human body together with the sheath tube.

10. The device according to claim 1, wherein the openings are provided in plurality, and the plurality of openings are evenly distributed in the circumferential direction of the sheath tube.

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